Following many surgical procedures in a living thing (human or animal) it is important or advantageous to be able to monitor in vivo the condition of surgical repair devices inserted during the procedure in order to monitor the healing progress of the surgical repair. Surgical repairs may fail, require repair or require removal for any number of reasons, including, inter alia, foreign body rejection, poor surgical repair device insertion, surgical repair device stretching or deforming and breaking or failure in some other detrimental fashion.
Typically useful surgical repair devices include non-absorbable polymeric sutures, which may be monofilamentary or multifilamentary and formed of polyamides or other synthetic polymers. Also in common use are polymeric foil and mesh implants. Foil implants are smooth polyamide or other synthetic polymeric, substantially planar sheets having a thickness from 0.01-2.0 mm. Mesh implants are woven or knit material of open texture formed of polyamide or other synthetic polymeric fabric.
Heretofore, surgical devices, such as stents, have been inserted into body lumens to maintain open lumen passageways and external imaging devices have been used to assure the accuracy of stent insertion and to monitor stent placement in the lumens. This monitoring, however, does not address the condition of the affected body part and does not inform the physician regarding the healing status of the body part. Illustrative of this is U.S. Patent Application Publication 2009/0076594, dated Mar. 19, 2009 to Sabaria which discloses stents which are generally cylindrical in configuration and formed of biodegradable, biocompatible and bioresorbable materials. The stents include one or more discrete or coated markers which may be detected external to the body by conventional imaging means, such as x-ray or other electromagnetic radiation detection methods, MRI or ultrasound, Preferably, the markers are applied by crimping a ribbon onto a strut of the stent, by partially sputtering a heavy metal coating onto all or part of the stent, or by any number of other techniques. The markers are used to monitor the deployment and placement of the stent at desired locations within lumens. Certain types of markers may be used to monitor the length, diameter and 3-D orientation of the stent in the lumen. However, for these purposes only discrete markers can be used which are specifically and accurately located on the stent in order to allow examining the location of the markers relative to one another. Thus, to determine stent length, first and second discrete markers are crimped onto the stent such that their spatial orientation is such that they lie on a line with a component vector parallel to the longitudinal axis of the stent. To determine stent diameter, first and second discrete markers are crimped onto the stent such that their spatial orientation is such that they lie on a line with a component vector perpendicular to the longitudinal axis of the stent. Likewise, to determine 3-D orientation, first and second discrete markers are crimped onto the stent such that their spatial orientation is such that they lie on a line with a component vector perpendicular to the longitudinal axis of the stent plus a third discrete marker is crimped onto the stent such that its spatial orientation is such that it lies on a line with a component vector parallel to the longitudinal axis of the stent. From this requirement for discrete markers to be placed at specific locations with specific orientations it follows that in order to have the ability to make dimensional measurements of the stent, the markers may not be uniformly dispersed throughout the stent. It is also noteworthy that these dimensional stent measurements bear no relevance whatever to the condition of the affected body part and do not inform the physician regarding the healing status of the body part. Likewise the use of these discrete markers to monitor the rate of pre-programmed degradation of different regions of the stent also bears no relevance whatever to the condition of the affected body part and does not inform the physician regarding the healing status of the body part.
It is, therefore, apparent that prior methods for monitoring surgical repair devices inserted within a living body were never intended to and do not provide a method of in vivo monitoring the condition of an internal surgical repair in a living body in which such repair devices were surgically inserted to effect the repair.